• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Ocean Queen USA, Inc., dba IMP Foods, Inc. 3/4/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700 

 

VIA UNITED PARCEL SERVICE
 
Our Reference: CMS 420561
 
March 4, 2014
 
Chihyang Ho, President
Ocean Queen USA, Inc.
1650 Delta Court
Hayward, California 94544

WARNING LETTER
 
Dear Mr. Ho:
 
We inspected your seafood processing facility located at 1650 Delta Court, Hayward, California, on January 8, 9, and 13, 2014. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your histamine forming fish and fishery products such as raw, ready-to-eat tuna, raw, vacuum packaged fish such as yellowtail, and raw, ready-to-eat salmon are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA’s home page at www.fda.gov.
 
At the close of our inspection, the FDA investigators provided Mr. Tung V. Ong, Branch Manager, with the form FDA 483, which presents their evaluation of your firm’s performance regarding various aspects of the HACCP requirements. We attached a copy of the FDA 483 for your reference.
 
We acknowledge receipt of Mr. Ong’s January 21, 2014 letter in response to the FDA 483 List of Observations issued to him on January 13, 2014. Mr. Ong’s response does not adequately address all the deviations observed during the inspection in that the revised HACCP plans were not presented. To determine the adequacy of your corrections, we will need to review your revised HACCP plans. The violations listed in this letter are based on the inspection and our review of Mr. Ong’s response.
 
Your significant violations are as follows:
 
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However,
 
(a)    your firm’s HACCP plan for “Yellowtail (Hamachi) Fillet Vacuum Pack Amberjack (Kampachi) Fillet Vacuum Pack Horse Mackerel (Aji) Fillet Vacuum Pack Red Snapper (Tai) Fillet Vacuum Pack” does not list the food safety hazard of histamine toxin formation.
 
(b)   your firm’s HACCP plan for “Fresh Salmon – refrigerated (aquaculture)” does not list the food safety hazard of pathogen growth and toxin formation at the Storage critical control point, for salmon intended for raw consumption. This deviation was noted upon further review of your HACCP plan.
 
2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s HACCP plan for “Fresh Salmon – refrigerated (aquaculture)” does not list the critical control point of Thawing to control pathogen growth and toxin formation in salmon intended for raw consumption.
 
3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However,
 
(a)    your firm’s HACCP plans for “FRESH Fish Histamine Producing Fish” and “Fresh Large Tuna” list a critical limit, (b)(4) at the Receiving critical control point that is not adequate to control histamine formation in fish intended to be cooked or consumed raw. Further, this critical limit is also not adequate to control pathogen growth and toxin formation in fish intended to be consumed raw.
 
(b)   your firm’s HACCP plan for “Fresh Salmon – refrigerated (aquaculture)” lists a critical limit, (b)(4) at the Receiving critical control point that is not adequate to control pathogen growth and toxin formation in salmon intended for raw consumption.
 
For items a and b above, in addition to an internal temperature critical limit, FDA recommends at the Receiving critical control point that you include the length of transit time (start time and end time), to demonstrate that the fish is delivered at your facility in less than 4 hours. This 4 hour limit should include all time that the product was outside a controlled temperature environment.
 
(c)    your firm’s HACCP plan for “Yellowtail (Hamachi) Fillet Vacuum Pack Amberjack (Kampachi) Fillet Vacuum Pack Horse Mackerel (Aji) Fillet Vacuum Pack Red Snapper (Tai) Fillet Vacuum Pack” lists critical limits (b)(4)  and (b)(4) that are not adequate to control Clostridium botulinum toxin formation. In addition to an internal temperature critical limit, FDA recommends at the Receiving critical control point that you include the start and end of the transit time, to demonstrate that the fish is delivered at your facility in less than 4 hours. This 4 hour limit should include all time that the product was outside a controlled temperature environment. 
 
Further, your HACCP plan lists a critical limit (b)(4) at the Cold Storage critical control point that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin formation. For refrigerated finished product storage, FDA recommends that the product is held at a cooler temperature of 38°F or below. This is more consistent with the monitoring procedure (b)(4) currently listed in your HACCP plan.
 
Please refer to Chapters 7, 12, and 13 of the Fish and Fishery Products Hazards and Controls Guidance (the Guide), 4th edition, for the appropriate monitoring procedures, corrective action, records keeping, and verification procedures which should be consistent with your critical limits.
 
4. You must have a HACCP plan that at a minimum lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However,
 
(a)    your firm’s HACCP plans for “FRESH Fish Histamine Producing Fish,” “Yellowtail (Hamachi) Fillet Vacuum Pack Amberjack (Kampachi) Fillet Vacuum Pack Horse Mackerel (Aji) Fillet Vacuum Pack Red Snapper (Tai) Fillet Vacuum Pack,” “Fresh Large Tuna Histamine producing fish,” and “Small Fresh Tuna” lists a monitoring frequency (b)(4) or (b)(4) at the Cold Storage critical control point, that is not adequate to control pathogen growth and toxin formation in fish intended to be consumed raw. In addition, this monitoring frequency is not adequate to control histamine formation in fish intended to be cooked or eaten raw and to control Clostridium botulinum toxin formation in vacuum packaged fish. FDA recommends continuous monitoring during storage, using a continuous temperature-recording device (e.g., a recording thermometer), with a visual check of the recorded or generated data at least once per day.
 
We acknowledge receipt of a letter from Mr. Tung V. Ong, Branch Manager, dated January 21, 2014, that you do not store or process “Small Fresh Tuna” at this facility so it will be removed from the HACCP plan. We will verify your correction at the next inspection.
 
(b)   your firm’s HACCP plan for “Fresh Salmon – refrigerated (aquaculture)” lists a monitoring frequency (b)(4) at the Storage critical control point that is not adequate to control pathogen growth and toxin formation in salmon intended for raw consumption.  Further, your monitoring procedure and frequency of (b)(4) for (b)(4) at the Freezing Process critical control point is not adequate to control parasite. FDA recommends monitoring the freezer temperature and the length of time fish is held at freezer temperature or held solid frozen, with a continuous temperature-recording device and performing a visual check of time and physical check of solid frozen condition. FDA also recommends continuous monitoring of the temperature with a visual check of the recorded data at least once per day during each freezing or storage period, and the length of time of freezing or storage period for each batch of fish.
 
5.  Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b).
 
(a)    However, your corrective action plan for “FRESH Fish Histamine Producing Fish” at the Receiving critical control point is not appropriate to control pathogen growth and histamine formation. It does not have provisions to ensure that the cause of the deviation is corrected; e.g., discontinue the use of the supplier or carrier until evidence is shown that transportation-handling practices have been improved. Further, your corrective action plan (b)(4) at the Cold Storage critical control point is not appropriate to control pathogen growth and histamine formation. Your plan does not ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation. In addition, your corrective action plan does not have provisions to ensure that the cause of the deviation is corrected; e.g., make repairs or adjustments to the malfunctioning cooler.
 
To address the pathogen hazard in raw, ready-to-eat fish, FDA recommends chilling and holding the product until it can be evaluated based on its total time and temperature exposure including exposures during prior processing operations.
 
To address the histamine hazard, you may wish to perform histamine analysis and destroy the lot if any fish is found with histamine equal or greater than 50 ppm, evaluate the product for time-temperature exposure, destroy the product, or divert it to a non-food use.
 
(b)   However, your corrective action plans for “FRESH Fish Histamine Producing Fish,” “Yellowtail (Hamachi) Fillet Vacuum Pack Amberjack (Kampachi) Fillet Vacuum Pack Horse Mackerel (Aji) Fillet Vacuum Pack Red Snapper (Tai) Fillet Vacuum Pack,” and “Fresh Large Tuna Histamine producing fish” list corrective actions at the Receiving and Cold Storage critical control points that are not appropriate to control pathogen growth and toxin formation including Clostridium botulinum toxin and histamine formation.   Your corrective action plans do not have provisions to ensure that the cause of the deviation is corrected.
 
(c)    However, your corrective action plan for “Fresh Salmon – refrigerated (aquaculture)” at the Receiving critical control point is not appropriate to control pathogen growth and toxin formation in raw, ready-to-eat salmon. In addition, your corrective action plan is not appropriate to control parasites at the Freezing critical control point in raw, ready-to-eat, non-pellet fed, aquacultured salmon. Your corrective action plan does not have provisions to ensure that the cause of the deviation is corrected. Further, your HACCP plan lists a corrective action plan (b)(4) at the Storage critical control point to control pathogen growth and toxin formation in raw, ready-to-eat salmon that is not appropriate. FDA recommends chilling and holding the product until it can be evaluated based on its total time and temperature exposure including exposures during prior processing operations.  Refer to Table A-2 in Appendix 4 of the Guide for acceptable exposure times with varying exposure temperatures.
 
(6) You must monitor sanitation conditions and practices with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
 
(a)     Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces – on January 9, 2014, the FDA investigators observed your employee in the cooler/processing room rinsing the floor and drain with a strong pressure water hose and saw the water splashed onto the processing tables. The investigators observed an employee processed tuna without cleaning and rinsing the table first.
 
(b)    Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants – on January 9, 2014, the investigators observed the ceiling directly above the end of the scaling machine conveyor belt appeared to have a build-up of mold or mildew. Fresh salmon (intended to be consumed raw) was going through the scaling machine; the scaled salmon was directly above the ceiling.
 
We acknowledge Mr. Ong’s response and corrective action to the above observations associated with sanitation. We will verify the effectiveness and permanence of the corrections at the next inspection.
 
The issues and violations described above are not meant to be an inclusive list of all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, including, without limitation, seizure and injunction of adulterated products under sections 302 and 304 of the Act [21 U.S.C. §§ 332 and 334].
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs.  A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)].  For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.  The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct these violations. You should include in your response, documentation such as copies of the revised HACCP plans, HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Please send your reply to the U. S. Food and Drug Administration, Attention: Lawton W. Lum, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. Please reference the CMS number 420561 in your response.
 
If you have questions regarding any issues in this letter, please contact Compliance Officer Erlinda Figueroa at (510) 337-6795.
 
 
Sincerely,                                                                   
/S/ 
Kathleen M. Lewis, J.D.
District Director
San Francisco District Office
 
 
cc: Mr.Tung V. Ong, Branch Manager